BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS ANALYZER

    MDR report key: 14380072 · Received May 12, 2022

    Report

    Report Number
    2250051-2022-00036
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 28, 2022
    Report Date
    September 29, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UNEXPECTED BEHAVIOR OF THE CARD IMAGING SYSTEM (LEADING TO ¿HYBRID¿ IMAGES) ON AN ORTHO VISION ID-MTS ANALYZER. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THE TIME OF THIS REPORT ALL RESULTS WERE FLAGGED AND REJECTED BY THE USER. NO BIASED RESULTS WERE REPORTED TO PHYSICIANS. NO PATIENT WAS HARMED.

    Additional Manufacturer Narrative · 0

    AN ORTHO INVESTIGATION HAS DETERMINED THAT THERE IS THE POTENTIAL FOR THE ORTHO VISION® ANALYZER AND THE ORTHO VISION® MAX ANALYZER FOR ID-MTS¿ GEL CARDS, TO USE MISMATCHED CAMERA IMAGES FOR ROUTINE IMAGING OPERATIONS. A COMMUNICATION (CL2022-243) WAS SENT ON 21SEP2022 AND ADVISED CUSTOMERS THAT UNTIL A SOFTWARE UPDATE IS AVAILABLE, WHEN THE ORTHO VISION ANALYZER POSTS A CIMS28, CIMS33, CIMS35, OR A CIMS02 ERROR CODE, TO PLEASE ABORT ALL TESTS IN-PROCESS, SHUT DOWN THE SYSTEM AND RESTART THE ANALYZER. RESTARTING THE ANALYZER WILL RESET THE SOFTWARE AND RESYNCHRONIZE CAMERA IMAGES TO RESOLVE THE USE OF MISMATCHED IMAGES. IN ADDITION, RESULTS GENERATED AROUND THE TIME THE ERROR CODE WAS REPORTED SHOULD BE REVIEWED FOR CONCORDANCE WITH KNOWN PATIENT INFORMATION, IF AVAILABLE. ORTHO¿S INVESTIGATION IS ONGOING AND ASSIGNABLE CAUSE HAS NOT YET BEEN DETERMINED. THE FDA WAS NOTIFIED OF THIS ISSUE ON 22SEP2022. US FDA RECALL REPORT NUMBER: 2250051-09/22/2022-001-C.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS AN UNEXPECTED BEHAVIOR OF THE CARD IMAGING SYSTEM OF THEIR ORTHO VISION ID-MTS ANALYZER EQUIPPED WITH SOFTWARE 5.13.2. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - LABORATORY TECHNOLOGIST. DATE OF EVENT: (B)(6) 2022. REPORTED ON: (B)(6) 2022 BY (B)(6) TO ORTHO CARE HELPDESK. REAGENTS: MTS ANTI-IGG GEL CARD LOT AND EXPIRY DATE NOT PROVIDED. MTS ABO-RH/REVERSE GEL CARD LOT AND EXPIRY DATE NOT PROVIDED. PATIENTS¿ INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, WHEN LOADING THE MTS GEL CARDS ON THEIR ORTHO VISION ID MTS ANALYZER, THEY HAD OBSERVED A DISCREPANCY BETWEEN THE INVENTORY DISPLAYED ON THE ANALYZER SCREEN AND THE ACTUAL CONTENT OF THE CARD DRAWER. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY THEY HAD A TESTED A PATIENT'S SAMPLE FOR ANTIBODY SCREENING AND THAT THE RESULTS ON THEIR ORTHO VISION ID MTS ANALYZER DID NOT APPEAR NORMAL. WITH THE HELP OF ORTHO CARE, THE IMAGE OF THE CARD WAS RETRIEVED, AND THE FRONT OF THE CARD APPEARS TO BE THAT OF AN ABO-RH/REVERSE GEL CARD WITH NO VISIBLE BARCODE AND THE BACK OF THE CARD APPEARS CORRECT BEING THAT OF AN ANTI-IGG GEL CARD. ORTHO CARE HAD CONFIRMED USING E-CONNECTIVITY THAT THIS GEL CARD WAS FLAGGED AND BROUGHT TO REVIEW RACK. ORTHO CARE HAD REVIEWED RESULTS: REPORT FIRST THREE WELL FLAGGED AS INDETERMINATE, LAST THREE WELLS FLAGGED AS WRONG LIQUID LEVEL. THE CUSTOMER WAS ASKED BY ORTHO CARE TO REBOOT THEIR ANALYZER WHICH RETURNED THE ANALYZER TO NORMAL OPERATION. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENTS HAD BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE SUPPLEMENTAL MDR REPORT WAS CREATED TO DOCUMENT THIS EVENT WAS REPORTED AS A CLASS II RECALL AND A COMMUNICATION WAS SENT TO CUSTOMERS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379985 ORTHO VISION ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown